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510(k) K922438

PRO2 OXYGEN ANALYZER by Martech Medical Products, Inc. — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1993
Date Received
May 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type

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  • K960519 — MARTECH ENDOSCOPIC INJECTION NEEDLE (May 1, 1996)
  • K931924 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (August 3, 1993)
  • K926007 — ACCESSORY TO PISTON SYRINGE (February 23, 1993)
  • K914778 — NEOLINE(TM) (September 16, 1992)
  • K910970 — MARKSMAN ARTERIAL BLOOD GAS SYRINGE (October 15, 1991)
  • K890473 — NEEDLE GUARD(TM) (April 3, 1989)

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